Danish Drug Standards

Updated 02 July 2021

A pharmaceutical company must ensure that its medicinal product and the raw materials used in the manufacturing process at least meet the requirements subject to which the medicinal product was authorised.

These requirements may concern the strength of the medicinal product, how fast it is dissolved, its purity, labelling, etc.

The Danish Medicines Agency takes part in the development of standards for the quality of medicinal products, which applies to medicines on the European market.

These standards are published in the European Pharmacopoeia (Ph. Eur.), which is prepared and published by the European Directorate for the Quality of Medicines & Healthcare (EDQM) in Strasbourg. You can read more about the EDQM and the European Pharmacopoeia at edqm.eu.

The standards in the European Pharmacopoeia come into force in Denmark by means of the executive order "Danish Drug Standards", which is published by the Danish Medicines Agency.

The Danish Drug Standards also contain standards that are not described in the European Pharmacopoeia which nonetheless apply to medicinal products on the Danish market.

The Danish Drug Standards are issued pursuant to section 52 of the Danish Medicines Act.

The Danish Drug Standards in force

Every three years in January, a new updated main version of the executive order “the Danish Drug Standards” is issued. Between these triennial issues, the main version is updated three times a year on the first day of January, April and July by way of eight consecutive executive orders to amend the executive order “the Danish Drug Standards”.

When a new main version of the Danish Drug Standards is issued, all versions of “executive order to amend the executive order on the Danish Drug Standards” published after the issue of the latest main version are marked as obsolete on Retsinformation.

The latest main version of the Danish Drug Standards is available at Retsinformation with the subsequent amendments available from the right-hand menu. The legal basis is made up of the latest main version of the Danish Drug Standards and the subsequent versions of the “executive order to amend the executive order on the Danish Drug Standards” published after the issue of the current main version of the Danish Drug Standards.

From 2020, the naming of the executive orders to amend the executive order on the Danish Drug Standards is changed. The names of these amending executive orders will now be based on the year of publication of the main version of the Danish Drug Standards (2020.1 to 2020.8) instead of the year of the publication of the individual executive orders. The new naming convention is to make it easier to identify the direct connection between the executive orders to amend the Danish Drug Standards and the supplement volumes to the European Pharmacopoeia. 

Under the Tables section below, you can find the tables of Raw materials in the Danish Drug Standards and Finished products in the Danish Drug Standards, which also include the previous separate table Medicinal products in the Danish Drug Standards. The tables are from the current main version of the Danish Drug Standards, which has since been updated with the amendments published in the subsequent versions of “executive order to amend the executive order on the Danish Drug Standards”.

Comments to the texts in Ph. Eur. 10.5

General monographs – Important notice

General notices

Comments concerning revised texts published in Supplement 10.5

The list of modified monographs in Ph. Eur. since the last update can be found in schedule 2 in the Danish Drug Standards and in the subsequent versions of the “Executive order to amend the executive order on the Danish Drug Standards”.

Tables

These tables represent the current status of raw materials and medicinal products in the Danish Drug Standards in 2020.5 / Ph. Eur 10.5:

Raw materials in the Danish Drug Standards 2020.5

Finished products in the Danish Drug Standards 2020.5

Danish monograph: Cannabis flower

The Danish monograph for Cannabis flower was updated with the entry into force of the Danish Drug Standards 2020.0. The updated monograph is found in schedule 3.

In the Danish Drug Standards 2020.3, the monograph for Cannabis flower has been updated with small corrections and clarification of the wording with no impacts on the interpretation of the monograph. The repeated first section has been deleted, and the formulas have been moved into place and corrected.

Error in the monograph for Cannabis flower: The monograph in the Danish Drug Standards 2020.3 contains an error in the structural formular for Δ8-THC. Instead of the correct structural formula, the THCA formula is found.

The correct structural formula for Δ8-THC is shown here:

 

 

Free access to EDQM’s Standard Terms database

It is possible to access the EDQM's Standard Terms database to get familiar with the applicable terms for pharmaceutical forms, container types, routes of administration, etc.

Anyone interested can access the database subject to personal registration at The website of the EDQM. The database is always up to date and also gives access to more details than the previous tables of the Danish Drug Standards and not least to a definition of the term.

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